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Efficacy and Safety of Ketoprofen Topical Patch 20% in the Treatment of Pain Associated With Ankle Sprain or Strain

Primary Purpose

Sprain, Strain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ketoprofen Topical Patch 20%
Sponsored by
APR Applied Pharma Research s.a.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sprain focused on measuring Sprain, Strain, Pain, Ankle Pain, Muscle, Bone and Cartilage Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Males or females 18 years of age or older Diagnosis of Grade I or Grade II ankle sprain or strain Meet pain entry criteria Willing to discontinue use of any pain medication not provided as part of the study Exclusion Criteria: Have a Grade 3 sprain or Grade 3 strain, bilateral sprain or strain, or concomitant fracture or wound at the site of the sprain or strain. Have received corticosteroids in the 30 days preceding screening Have a history or physical examination finding that is incompatible with safe participation in the study Have a history or physical examination finding that is incompatible with study product use Are taking medications or other substances contraindicated due to the nature of the study medication or the potential for drug interactions. Are taking medications that may significantly affect renal function

Sites / Locations

  • PPD

Outcomes

Primary Outcome Measures

Average pain intensity during daily activities

Secondary Outcome Measures

Average pain intensity while at rest; Functional disability; Use of rescue medication; Quality of sleep; Patient's and physician's global assessments of study medication

Full Information

First Posted
June 30, 2006
Last Updated
February 17, 2020
Sponsor
APR Applied Pharma Research s.a.
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1. Study Identification

Unique Protocol Identification Number
NCT00351104
Brief Title
Efficacy and Safety of Ketoprofen Topical Patch 20% in the Treatment of Pain Associated With Ankle Sprain or Strain
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase III Study of the Efficacy, Tolerability and Safety of Ketoprofen Topical Patch, 20% (KTP) in the Treatment of Pain Associated With Grade 1 or Grade 2 Ankle Sprain or Strain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
APR Applied Pharma Research s.a.

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain associated with ankle sprain or strain.
Detailed Description
This randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with Grade 1 or Grade 2 ankle sprains or strains. Eligible patients will be randomized (in a 1:1 ratio) to receive double-blind treatment with either the KTP or a matching placebo patch to be applied once daily for 14 days. Patients will return to the clinic for assessments on Day 3, Day 7 and Day 14; a follow-up assessment will be conducted by telephone on Day 28. At each visit through Day 14, patients will rate their average pain intensity during daily activities and while at rest using an 11-point scale, and will rate their functional disability. Patients will also complete an electronic diary in which pain intensity and pain relief ratings will be recorded three times daily. Ratings of the quality of sleep will be recorded in the diary each morning, and the use of study treatment and rescue medication will be recorded in the diary each day. Ibuprofen will be provided as rescue medication

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sprain, Strain
Keywords
Sprain, Strain, Pain, Ankle Pain, Muscle, Bone and Cartilage Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ketoprofen Topical Patch 20%
Primary Outcome Measure Information:
Title
Average pain intensity during daily activities
Secondary Outcome Measure Information:
Title
Average pain intensity while at rest; Functional disability; Use of rescue medication; Quality of sleep; Patient's and physician's global assessments of study medication

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males or females 18 years of age or older Diagnosis of Grade I or Grade II ankle sprain or strain Meet pain entry criteria Willing to discontinue use of any pain medication not provided as part of the study Exclusion Criteria: Have a Grade 3 sprain or Grade 3 strain, bilateral sprain or strain, or concomitant fracture or wound at the site of the sprain or strain. Have received corticosteroids in the 30 days preceding screening Have a history or physical examination finding that is incompatible with safe participation in the study Have a history or physical examination finding that is incompatible with study product use Are taking medications or other substances contraindicated due to the nature of the study medication or the potential for drug interactions. Are taking medications that may significantly affect renal function
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PPD
Organizational Affiliation
PPD Austin, TX
Official's Role
Principal Investigator
Facility Information:
Facility Name
PPD
City
Austin
State/Province
Texas
ZIP/Postal Code
78704
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of Ketoprofen Topical Patch 20% in the Treatment of Pain Associated With Ankle Sprain or Strain

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